The clinical trial process is also known as clinical research, clinical studies, medical trials, medical research, clinical studies and human trials. So what exactly does the whole clinical trial process involve? How do medications make it from the research lab to the pharmacy counter and eventually into your home?
First off the researchers do their initial studies, also known as pre-clinical trials in the lab on tissue samples and in animals. The reason for trying new treatments out in animals first is to determine, first and foremost, if there are any possible benefits of the treatment as well as any potential side effects (this part of the clinical trial process can take up to a few years to produce results). If after this something looks promising as a treatment for a particular disease then they will begin to do the actual clinical trials. The goals of the clinical trials process are to find out:
if a new treatment is safe and effective for use
what doses and dose forms (tablet, liquid, injection, suppository, etc) are best-suited for the new treatment
if, compared to other treatments for the disease in question, the new treatment is better
Be aware though that clinical trials are not limited only to discovering new drugs, they also are also conducted to find new ways of using already-existing drugs and treatments as well as for finding new treatment procedures altogether.
Many different people are involved in the clinical trial process, from those who fund (pay for or sponsor) them to those who participate in them in various different capacities. These trials and research studies can be funded by institutions, governments or government agencies, hospitals, consumer associations or pharmaceutical/biotechnology/medical device companies. Other people who are involved in the process include:
those who design and implement the studies such as scientists, doctors, nurses, etc.
volunteers, also known as study subjects, who participate in the trials
other healthcare professionals who are responsible for seeing the volunteers and collecting the data, these could doctors, nurses, pharmacists, scientists, data managers, etc.
trial monitors, these are the people who monitor and oversee the trial to make sure that it is being done correctly; these include clinical research associates, data managers, quality assurance managers, etc.
those who analyze, collate and finally publish the data
The clinical trial process has the potential to vary from site to site so in an effort to develop some consistency in the conduction of clinical trials guidelines were set up. Known as the International Conference on Harmonization/World Health Organization Good Clinical Practice guidelines, or Good Clinical Practice or ICH-GCP for short. Their goal is to ensure that the rights, safety and well-being of human subjects in clinical trials are protected and that only those trials that are scientifically justified are performed, and finally that the data that is generated from such trials is accurate and credible.
Clinical Trial Phases:
The clinical trial process is divided into three (and sometimes four) main phases. These phases of clinical trials are applicable when a drug or a medical device is being tested/researched. The end point of each phase seeks to answer a specific question.
Phase III - How does it compare to standard treatments already being used? What is the best dose?
Phase IV - What happens to people who are using a particular medication or device that has been approved by the FDA?
In order to be truly valid, these trials must be well-controlled and to achieve this there must be a comparison between those being treated with the new agent and a control population. The reason for doing this is so that the effect of the new treatment can be determined and distinguished form other phenomena like concomitant treatments, observer or patients' pre-conceived expectations, natural spontaneous changes, or even placebo effects. According to the FDA, there are five different types of controls that can be used in the clinical trial process to achieve this purpose and they are:
Placebo-controlled trials
Dose-comparison trials
Concurrent "no-treatment" arm controlled trials
Concurrent "active-treatment" arm controlled trials
Retrospective or Historical trials
In addition to the different phases of clinical trials, there also different types of clinical trials. These include:
Prevention Trials - these trials try to find ways to reduce the risk or chance of developing a particular disease or condition.
Treatment Trials - these focus on finding new ways of using a standard treatment (device, drug or even surgical procedure).
Screening Trials - these focus on identifying people who have, or run the risk of having, a particular disease or health condition before there are any evident symptoms of it.
Diagnostic Trials - these trials focus on finding new diagnostic tests and/or procedures that may help to identify or diagnose a particular disease better or earlier.
Biomarker or Genetic Studies - these specialized studies look at how biomarkers or genes may be linked to the detection or diagnosis of a condition or how they may influence a person's response to treatment. These studies may also go by such fancier names as pharmacogenetic, or pharmacogenomic studies.
The Clinical Trial Process Step by Step
Come up with a new research topic or develop a new drug or medical device for testing
Prepare a document that explains why, what, who, when, where and how of the clinical trial... also known as the clinical trial protocol
Get the money for study, the people you'll need to study, the sites where the studies will be conducted, the equipment you'll need and any and all other necessary operational requirements
Submit the trial for an ethical and scientific review. These reviews are conducted in the United States by an Institutional Review Board (IRB) or in the United Kingdom and Australia by the Human Research Ethics Committee (HREC). If the project receives approval form the ethics committee then proceed with the following steps:
Train the staff that will be involved in the trial and supply them with the necessary equipment and materials they will
Monitor the trial on an ongoing basis and make sure that the protocol and all the regulatory requirements are being adhered to
Collect the data
Wrap up the trial... close down all trial sites and gather, archive and store all the trial documentation
Publish the study results
Done!
A few simple steps yes, but the length of time it takes to conduct a clinical trial can vary anywhere from a few weeks to years. Though the outcome of trials is not always positive and does not always produce a new and novel drug or treatment, something is always learned along the way.
The student is to collect and evaluate facts. The facts are locked up in the patient.
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